SEC Connect
Exhibit 99.1
Innovus Pharma
Announces Commercial Partnership to Launch
FlutiCare™
Under FDA Approved ANDA No. 207957
-FlutiCare™ Will be the Third Branded
Fluticasone Propionate Nasal Spray Sold in the United
States
San Diego, Calif., May 9, 2017 – Innovus Pharmaceuticals,
Inc. (the “Company” or "Innovus Pharma") (OTCQB Venture
Market: INNV) and its partner West-Ward Pharmaceuticals
International Limited (“WWPIL”), a wholly-owned
subsidiary of Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ
Dubai: HIK) (OTC: HKMPY), today announced that WWPIL will provide
the Company with the rights to launch its branded, fluticasone
propionate nasal spray USP, 50 mcg per spray (FlutiCare™),
under WWPIL’s FDA approved abbreviated new drug application
(“ANDA”) No. 207957, in the United States in the second
half of 2017. FlutiCare™ is the first and only nationally
branded OTC product under approved ANDA No. 207957 in the US
market. FlutiCare™, which is equivalent to
Flonase®
by GlaxoSmithKline and
ClariSpray®
by Bayer, is the third national brand
being marketed and sold in the U.S. Innovus Pharma will be
launching the 120-spray version through its Beyond Human®
sales and marketing platform, through other online channels,
directly to its over two million e-mail subscribers, and through
select retail stores.
FlutiCare™ (fluticasone propionate nasal spray USP, 50mcg per
spray) is indicated for the temporary relief of hay fever and other
upper respiratory allergies in adult and pediatric patients 4 years
of age and older.
"Having
an approved ANDA drug in our product portfolio in a very large
indication and being one of only three national brands in the U.S.
is a great and long awaited achievement for Innovus Pharma," said
Dr. Bassam Damaj, President and Chief Executive Officer of the
Company. “We are putting significant efforts into the launch
of FlutiCare™ in the U.S. in the second half of this year
through our Beyond Human® Sales and Marketing platform, our
other on-line channels and select retail store sales
channels.”
The
Company currently expects between $10-15 million in additional
revenue from the sales of FlutiCare™ in the U.S. in the first
full 12 months from the launch date.
This is
the second partnership Innovus Pharma has announced for its
FlutiCare™ product. The first, originally announced in
connection with the Company’s acquisition of Novalere FP,
Inc. in 2015, is pending FDA approval of the ANDA in the U.S. As a
result of the acquisition, Innovus Pharma owns worldwide rights
outside of the U.S. to this dossier and filing and intends to
commercialize FlutiCare™ through the use of its rights to the
U.S. dossier for the product.
The
Company’s relationship with WWPIL for FlutiCare™ allows
Innovus Pharma to launch the product in the U.S. on a shorter
timeline instead of waiting for the approval of the first ANDA. In
addition, Innovus Pharma believes that having two manufacturers, of
which WWPIL is the sole manufacturer for FlutiCareTM in the US market,
is an advantage to ensure continuous product
availability.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging
over-the-counter (“OTC”) consumer goods and specialty
pharmaceutical company engaged in the commercialization, licensing
and development of safe and effective non-prescription medicine and
consumer care products to improve men’s and women’s
health and vitality and respiratory diseases. Innovus Pharma delivers innovative and uniquely
presented and packaged health solutions through its (a) OTC
medicines and consumer and health products, which we market
directly, (b) commercial partners to primary care physicians,
urologists, gynecologists and therapists, and (c) directly to
consumers through our on-line channels, retailers and wholesalers.
The Company is dedicated to being a leader in developing and
marketing new OTC and branded Abbreviated New Drug Application
(“ANDA”) products. The Company is actively pursuing
opportunities where existing prescription drugs have recently, or
are expected to, change from prescription (or Rx) to
OTC.
For more information, go to www.innovuspharma.com,
www.zestra.com;
www.ejectdelay.com;
www.myvesele.com;
www.sensumplus.com;
www.myandroferti.com;
www.fluticare.com;
www.beyondhumantestosterone.com;
www.getbeyondhuman.com;
www.trybeyondhuman.com.
Innovus Pharma's Forward-Looking Safe Harbor:
Statements
under the Private Securities Litigation Reform Act, as amended:
with the exception of the historical information contained in this
release, the matters described herein contain forward-looking
statements that involve risks and uncertainties that may
individually or mutually impact the matters herein described for a
variety of reasons that are outside the control of the Company,
including, but not limited to, receiving patent protection for any
of its products, to successfully commercialize FlutiCare™ and
other products in the U.S. and internationally and to achieve its
other development, commercialization, financial and staffing
objectives. Readers are cautioned not to place undue reliance on
these forward-looking statements as actual results could differ
materially from the forward-looking statements contained herein.
Readers are urged to read the risk factors set forth in the
Company's most recent annual report on Form 10-K, and other filings
made with the SEC. Copies of these reports are available from the
SEC's website or without charge from the Company.
The
trademark Flonase®
is a registered trademark owned by
GlaxoSmithKline and the trademark ClariSpray®
is a registered trademark owned by
Bayer.
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Contact:
Kevin
Holmes
Chesapeake
Group
410-825-3930
info@chesapeakegp.com